A randomized controlled trial is conducted to evaluation of the effects of virtual reality and local cold-vibration applications in reducing anxiety, fear and pain due to intramuscular (IM) injection in children aged 5-10 years. It has been determined that the use of Virtual Reality and local cold-vibration are effective interventions in reducing anxiety, fear and pain due to IM injection in children aged 5-10 years.
Who can participate
Age range
5 Years – 10 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
The child is between the ages of 5 and 10
Having intramuscular (IM) injection therapy
Absence of Audio-Visual-Sensation loss problem
No communication problem
Absence of mental retardation
Absence of a disease causing chronic pain
No history of fainting during injection
Not taking any analgesic medication in the last 4 hours
Exclusion Criteria:
Failure of IM application at one time
The child in the virtual reality application group removes the virtual reality glasses during the IM injection.
The child in the group receiving Buzzy application removes the Buzzy device during IM injection.
Not wanting to fill the scales after the application
Diagnosis or suspicion of COVID-19 (having any of the symptoms such as fever, cough, respiratory distress, chest pain, loss of taste and smell, sore throat, contact with a COVID-19 positive person)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anxiety assesed by Children's State Anxiety
Timeframe: Before the intramuscular injection
2
Anxiety assesed by Children's State Anxiety
Timeframe: Within the first 5 minutes after the intramuscular injection
3
Fear assesed by Child Fear Scale
Timeframe: Before the intramuscular injection
4
Fear assesed by Child Fear Scale
Timeframe: Within the first 5 minutes after the intramuscular injection
5
Pain assesed by Wong-Baker FACES
Timeframe: Before the intramuscular injection
6
Pain assesed by Wong-Baker FACES
Timeframe: Within the first 5 minutes after the intramuscular injection